Specialist Study Start Up & Regulatory Affairs

About the role

The Specialist, Study Start Up and Regulatory is responsible for completing study start‑up and regulatory deliverables based on an established SSU/RA management plan. They act as a liaison between the SSU/regulatory project team, authorities, vendors and investigative sites to ensure timely and compliant study initiation.

Key responsibilities

• Prepare, collect and review regulatory information for submissions to national authorities and ethics committees, ensuring compliance with applicable regulations.
• Collect, review for completeness and track essential documents for study start‑up, investigating any gaps to guarantee accurate site initiation.
• Draft, negotiate and execute clinical site agreements and ancillary contracts at country or regional level within projected timelines.
• Coordinate site outreach, manage confidential disclosure agreements and support site activation readiness, including investigational product release.
• Maintain project trackers, file documents in the study portal and Trial Master File (TMF), and perform quality checks on submission dossiers.

Required profile

• Graduate degree in Chemistry, Life Sciences, Pharmacy, MD or equivalent combination of education and experience.
• Previous experience within the pharmaceutical or CRO industry.
• Good knowledge of ICH GCP and national regulations for the territories of competency.
• Strong written and verbal communication skills to present information clearly and concisely.
• Proficiency in English, both written and spoken.

Required skills

• Knowledge of ICH GCP guidelines.
• Proficiency in English language.